Press Release: Thelin (sitaxentan) to be withdrawn due to cases of unpredictable serious liver injury

Awdur (Corfforaethol)
Teitl y Gyfres
Manylion y Gyfres EMA/804365/2010 (10.12.10)
Dyddiad Cyhoeddi 10/12/2010
Math o Gynnwys

The European Medicines Agency (EMA) was informed, in December 2010, of Pfizer’s decision to voluntarily withdraw Thelin from the market worldwide further to new information on two cases of fatal liver injury. Pfizer had also decided to discontinue all ongoing clinical trials.

Thelin, which contains the active substance sitaxentan, has been authorised in the European Union (EU) since 2006 for the treatment of pulmonary arterial hypertension.
Dolen Ffynhonnell Link to Main Source http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2010/12/news_detail_001161.jsp&mid=WC0b01ac058004d5c1&murl=menus/news_and_events/news_and_events.jsp
Dolenni Cysylltiedig
EMA: Public Statement: EMA/149536/2011 (2.3.11)Public statement on Thelin: Withdrawal of the marketing authorisation in the European Union http://www.ema.europa.eu/docs/en_GB/document_library/Public_statement/2011/03/WC500102595.pdf
EMA: Press Release: EMA/804365/2010 (10.12.10) http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2010/12/WC500099707.pdf
EMA: Press Release; EMA/CHMP/819948/2010 (16.12.10): Update on the withdrawal of Thelin http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2010/12/WC500099940.pdf
Categorïau Pwnc
Gwledydd / Rhanbarthau